Multiple clinical trials open to patients on the Peninsula

Prue Salasky, psalasky@dailypress.com | 757-247-4784

Almost half the medical clinical trials in Virginia are taking place in Hampton Roads. Of the more than 120 privately funded active trials enrolling patients, half involve treatment for major chronic illnesses, such as cancer, diabetes and heart disease, according to PhRMA, a trade organization representing 32 pharmaceutical companies.

Awareness of clinical trials is key for both the pharmaceutical and medical device companies that sponsor them and for patients seeking cutting-edge treatment that's otherwise unavailable. More than 70 percent of trials have trouble getting the right patients, which results in costly delays in drug development and reduced access to therapeutic care, according to CenterWatch, a clinical trial organization.

PhRMA credits the research studies with bringing an economic, educational and therapeutic boon to the region.

Among them, Sentara Cardiovascular Research Institute in Norfolk is investigating a new laser used to treat atrial fibrillation, the most common form of irregular heart rhythm, which affects 2.3 million people in the U.S. In February, Sentara announced it had enrolled 21 patients, more than half of its targeted participants. In all, the national study expects to enroll 400 patients at 23 sites.

Local participant Robert Davis, 58, of Chesapeake, has suffered from atrial fibrillation, which he described as "an electrical storm, like lightning in my heart" since his 20s. "You feel terrible. You feel run down, irritated, dizzy, nauseated, you feel you're going to black out," he said. He knew about traditional ablation but was afraid that it wouldn't improve the problem. He kept waiting for the technology to improve. Then, his physician, Ian Woollett, a cardiac electrophysiologist with Cardiovascular Associates, and lead investigator for the CardioFocus HeartLight Endoscopic Ablation System study approached him about the new device. In April 2012, Davis was the first patient to undergo the procedure. "I'm just so delighted. I feel wonderful," he said a year later.

In a randomized study, such as the HeartLight, half the study participants are treated with the study device and half with the current standard of care. In the latter, one in three patients typically requires additional treatment, said Woollett. "I don't pressure anyone, but it's like nothing I've ever seen. It gives the ability to visually look inside the heart and the ability to give lines where there are no gaps. That's why I'm excited and have reason to think it's good." He has found that 80 percent of his patients who are eligible accept participation. "It's exciting to be able to offer patients something they can't get elsewhere," he added.

Woollett is also involved in other research regarding blood thinners and stroke prevention. Because the placebo effect is so strong, he said, studies are conducted "blind," that is without patients knowing which treatment they're receiving; however, patients cannot be given less than the current standard of care.

On the Peninsula, Riverside Regional Medical Center has a couple of active trials in cardiac research, according to spokesman Peter Glagola. It is currently recruiting patients with acute myocardial infarction, coronary occlusion and acute coronary syndrome intervention in the use of the AngelMed Guardian system. It is also recruiting for a study on azimilide in heart patients with an implantable cardioverter defibrillator. Ongoing studies that are no longer accepting patients include a study on the efficacy of edoxaban as compared to the blood thinner warfarin in subjects with atrial fibrillation; and one evaluating the safety and efficacy of the OPTIMIZER system with heart failure patients.

At the Liver Institute of Virginia at Bon Secours Health System, with offices in Newport News and Richmond, hepatologist Mitchell Shiffman is involved in 22 clinical trials for Hepatitis B, Hepatitis C and other liver disorders. "We use clinical trials to get better, more effective, less toxic treatments to better take care of patients," he said. The drive is toward developing oral antiviral drugs and avoiding interferon-based therapy which has a high efficacy rate but comes with severe flu-like side effects. "We hope to make it more tolerable and increase the cure rate," Shiffman said, noting that he has 10 times as many willing participants as slots in his trials.

In all cases, patient safety is the prime concern, the researchers emphasize. "Patient safety is first and foremost," said Shiffman.

To find out more about clinical trials, go to http://www.clinicaltrials.gov.